When COVID-19 was declared a Public Health Emergency (PHE), the Secretary of HHS was authorized to waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program, HIPAA, and EMTALA requirements. Many healthcare organizations employed these waivers or modifications by implementing temporary policies and procedures to ensure their ability to rapidly adapt to changing patient volumes and demand for providers, supplies, and equipment during the PHE. Because many of the PHE waivers and flexibilities relaxed rules related to high-priority areas for CMS, King & Spalding expects that investigations and enforcement will begin around flexibilities that will be rolled back with the expiration of the PHE.

The Secretary has waived or modified nearly 200 healthcare regulatory requirements in connection with the PHE. Most of the waivers were retroactive to March 1, 2020, while others were effective later in 2021 as the PHE continued to evolve. While some waivers, such as those associated with certain aspects of telemedicine, may become permanent after appropriate rulemaking processes, many of the waivers or modifications are expected to end upon the expiration of the PHE. Some waivers or modifications have already concluded or were already limited in time and scope when they were issued.

Because variants of COVID-19 continue to develop and many hospitals remain overcrowded and understaffed, the PHE has been extended into 2022. However, the PHE and therefore the CMS waivers are not expected to last indefinitely. Because many waivers and modifications relaxed rules associated with the Conditions of Participation, provider enrollment or licensure, and compliance with the Stark Law, King & Spalding anticipates increased investigations and enforcement of the rules at the conclusion of the PHE. Given the speed and urgency with which healthcare organizations had to respond to the pandemic, they may not have a comprehensive view into which waivers they are relying upon for their current policies and procedures. As a first step, healthcare organizations should inventory the waivers they have implemented.

In preparation for the expiration of the PHE, organizations should also develop a plan to unwind the interim policies and procedures they put in place when the regulatory waivers and flexibilities were established. Organizations’ plans to unwind the steps taken to implement the waivers should include:

• a list of staff members who are responsible for each waiver;

• the policies, procedures, forms, and communication mechanisms that changed because of each waiver;

• a timeline for reestablishing all regulatory requirements; and

• a review of each regulatory standard to ensure reinstituted policies and procedures meet all recent updates to previously-waived regulations (for example, some telehealth waivers will not revert to their original state but will either retain the waived components of the original regulation or some altered version of waived rules).

To assist organizations in this assessment and planning process, King & Spalding’s healthcare compliance practice has developed a unique PHE Assessment Toolkit. The Toolkit is designed to help healthcare entities identify which PHE waivers they implemented and to provide direction on how to unwind them upon the conclusion of the PHE. The Toolkit enables healthcare organizations to evaluate each potential regulatory waiver or modification and determine whether it was implemented and in which areas or departments. The Toolkit also provides a framework for organizations to establish the necessary steps to retract its provisional policies and procedures and reinstitute those that comply with federal healthcare laws, rules, and regulations. Using the Toolkit, healthcare organizations can sort by the level of risk associated with each waiver, so they can prioritize their activities around unwinding the processes they implemented when they employed the waiver. For example, there are 18 waivers associated with the Stark Law. These waivers are high risk for healthcare organizations. One example is the ability of healthcare entities to pay a physician above or below FMV for personally-performed services to the entity. Similarly, certain Stark Law sanctions have been waived in the context of physician referrals made by a physician owner of a hospital for specific exceptions related to ownership and investment interests.